Until now, clinicians have had to trade off the speed and relative ease of use of conventional highly parallel individual assays, against the information richness, but complexity and unwieldiness of NGS.

DNAe bridges this gap with the LiDia diagnostic platform, where analysis and read-out take place on a single chip. There’s no need to measure optical signals or use lasers and microscopes.

LiDia can perform highly parallel individual assays and NGS on the same type of chip. Depending on the particular instrument and test configuration, LiDia can perform a range of genomic analyses, to arrive at fast, accurate and insightful diagnoses.

We believe the impact of our technology will be substantial.

Not because it offers the longest read lengths, or the lowest cost per base, or the highest output per run – the traditional battlegrounds for research-based DNA sequencers –in clinical diagnostic sequencing applications. But because, in every scenario, it is a complete end-to-end solution that quickly leads to a clinically actionable result, without special skills or high start-up and running costs, or the need for a specialized lab.

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A Complete End-to-End Diagnostic Solution For a Fast Actionable Result

We use the established, standard building block of modern microelectronics - the silicon transistor - to detect DNA as a simple electrical signal.

Nucleotides that incorporate during DNA sequencing or amplification release hydrogen ions, which can be detected as an electrical signal. If there is no match, no hydrogen ions are released and no signal is detected.

This method can be universally applied to any DNA and RNA analysis on a standard CMOS semiconductor chip.

There’s no need for fluorescent dyes or labels, or precision optics, which make current DNA analysis equipment bulky and expensive.

unprecEdented effeciency, sensitivity and specificity

Fully automated sample preparation

Our unique sample preparation solution is designed to meet demanding applications where a few targets are present in the sample.

For our first product, it allows the rapid detection of pathogens in blood. The Pathogen Capture System accepts a standard 10 mL green-top Vacutainer™ containing whole blood which is loaded into a single-use cartridge.

Once the cartridge is inserted into the instrument, the clinical specimen is processed using a proprietary mixture of immunomagnetic beads that specifically and rapidly extract bacterial and fungal pathogens at concentrations as low as 1 CFU/mL. The ability to capture and concentrate low concentration pathogens in a complex matrix eliminates the need for blood culture and significantly reduces the time to detect pathogens – from days to 3 hours, allowing a clinician to administer appropriate antibiotics at the point-of-need.

To eliminate the risk of false positive signals from environmental DNA contaminants in downstream ID, DNAe has developed DNA-free manufacturing processes for all cartridge reagents and materials.

Intellectual property

DNAe has developed a wide portfolio of patents and know-how around semiconductor technology, systems engineering and molecular biology for life science applications.

Since we invented semiconductor DNA detection using pH, we have created many innovative and practical solutions to speed up, simplify and enrich diagnostics at the point-of-need.

Our core patents cover the following innovations:

Label-free pH-mediated detection of DNA and RNA using semiconductor ion sensors known as ion-sensitive field effect transistors (ISFETs)

DNA sequencing by ISFETs through the detection of hydrogen ions released from nucleotide incorporation

Novel, low power electronic interfacing techniques

pH-based methods for simultaneous amplification and detection of nucleic acids

Highly sensitive sample preparation using immuno-magnetic separation.

Licensees

DNAe has granted limited, non-exclusive licenses to certain patents to a small number of life science companies, including Ion Torrent (now part of Thermo Fisher Scientific). As a result, DNAe’s technology is now proven for next generation sequencing in laboratories around the world. DNAe retains exclusive rights to its technology for sequence detection via amplification.